Nex-D2 CBCAJ-10000Recalls & reported problems
Next Orthosurgical, Inc. · SET SCREW, BLUNT START, T-30 HEXALOBE · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840314141798), received between Jul 9, 2025 and Jan 20, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Improper or Incorrect Procedure or Method1
- Migration1
Patient problems
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
- Spinal Column Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2026Device Dislodged or Dislocated
A PATIENT WHO UNDERWENT SPINAL SURGERY ON (B)(6) 2024, WAS LATER FOUND TO HAVE DISLOCATION OF THE L4 RIGHT SET SCREW ASSOCIATED WITH THE IMPLANTED PEDICLE SCREW SYSTEM. ON (B)(6) 2025, THE TREATING PHYSICIAN CONFIRMED THE DISLOCATION. AS A RESULT, A SECOND SURGICAL INTERVENTION WAS PERFORMED ON (B)(6), 2025, DURING WHICH THE L4 RIGHT PEDICLE SCREW, SET SCREW, ROD, AND THE L5 RIGHT ROD AND SET SCREW WERE REMOVED. THE L4 PEDICLE SCREW WAS REPLACED WITH AN UPSIZED 7.8 Ã 50 MM PEDICLE SCREW, AND FINAL FIXATION WAS ACHIEVED USING A NEW ROD AND SET SCREW. THE RE-OPERATION WAS COMPLETED SUCCESSFULLY. NO DEVICE SAMPLE WAS AVAILABLE FOR RETURN OR EVALUATION.
Patient problems: Joint Dislocation
MAUDE report 24119160 ↗InjuryJul 9, 2025Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration
ON (B)(6) 2024, AN INITIAL OPERATION WAS PERFORMED ON A PATIENT EXTERNALLY FIXATING THE L4-L5 VERTEBRAE USING PEDICLE SCREWS. THEN ON (B)(6) 2025, THE DOCTOR CONFIRMED THAT THE L4 RIGHT SET SCREW WAS DISLOCATED. A REOPERATION WAS PERFORMED ON (B)(6) 2025 AND THE L4 RIGHT PEDICLE SCREW, SET SCREW, ROD, AND THE L5 RIGHT SET SCREW WERE REMOVED. THE PEDICLE SCREW WAS REPLACED WITH A LARGER OD USING SCREW SIZE 7.8 X 50 MM. THE ORIGINAL PEDICLE SCREW SIZE USED WAS A 7.0 X 50 MM. A NEW ROD AND SET SCREWS WERE IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Spinal Column Injury
MAUDE report 22464873 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.